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COVID-19 and Unmet Needs:

SARS-CoV-2 is a zoonotic strain of coronavirus that was first detected in human populations in the Chinese province of Hubei in late 2019. The spread of infection has since been driven by human-to-human transmission resulting in the 2020-2021 pandemic.

As a result of unprecedented public and private sector initiatives, as well as the advent of mRNA and viral vector technologies, new vaccines against COVID-19 disease received regulatory clearance in multiple countries in record time. Still, a multi-year track record of safety and efficacy of these new platforms has yet to be established with vulnerable populations, especially those most directly impacted by the current pandemic – the elderly. Additionally, mRNA vaccines require expensive supply chain support, and there may be certain limitations to the viral vector-based products. Coupled with new mutations of the SARS-CoV-2 virus identified in South Africa and the UK for which the new vaccines may or may not provide robust protection, there is a need for ongoing research. Traditional subunit vaccines or virus-like particle alternatives may have a role in managing the pandemic, particularly constructs that can be cost-effectively designed, prototyped, and mass produced in rapid fashion.1

iBio’s Approach

Having only just begun our own proprietary product development initiatives in December 2019, we sought to demonstrate our FastPharming® System’s capabilities with the new, emerging SARS coronavirus in late January 2020, even though the pandemic to come was not envisioned at the time.  Within five weeks, we designed and manufactured constructs using two platforms, one a virus-like particle [VLP], and the other a subunit vaccine that combines antigenic sequences derived from SARS-CoV-2 virus spike protein fused with our patented LicKMTM booster molecule. Subsequent preclinical studies with an array of adjuvants suggested the subunit vaccine, IBIO-201, held more promise.  So, additional work was conducted to establish the platform (e.g. toxicology studies on viral proteins fused to LicKM).

The recent appearance of coronavirus mutations has raised concerns about emerging virus variants which may at some point evade protection from currently available vaccines and has led us to focus on other viral proteins that may provide broader protection against the new coronavirus mutations. The SARS-CoV-2 N protein contains immunogenic epitopes and is more highly conserved than the S protein among the viral variants. New viral variants may be less likely to escape vaccine protection if vaccines include conserved sequences.2,3,4,5 The N protein targeting strategy of IBIO-202 is complementary to existing first-generation, S protein-directed mRNA vaccines and may be suitable as a second-generation coronavirus vaccine.

Development Status

IBIO-202 constructs have been successfully expressed using iBio’s plant-based FastPharming System and are currently being tested in preclinical studies to identify those antigens that maximize immune protection and offer high manufacturability.

IBIO-201 completed preclinical studies to evaluate immune responses in mice and generation of neutralizing antibodies to SARS-CoV-2 spike protein in 2020. IBIO-201 recently completed IND-enabling toxicology studies with no adverse effects at low or high doses.
References
  1. Collier, D.A., De Marco, A., Ferreira, I.A.T.M. et al.Sensitivity of SARS-CoV-2 B.1.1.7 to mRNA vaccine-elicited antibodies. Nature 593136–141 (2021)
  2. Zhao, P. et al. Immune responses against SARS-coronavirus nucleocapsid protein induced by DNA vaccine. Virology 331, 128–135 (2005).
  3. Oliveira, S. C., de Magalhães, M. T. Q. & Homan, E. J. Immunoinformatic Analysis of SARS-CoV-2 Nucleocapsid Protein and Identification of COVID-19 Vaccine Targets. Front. Immunol. 11, (2020).
  4. Dutta, N. K., Mazumdar, K. & Gordy, J. T. The Nucleocapsid Protein of SARS–CoV-2: a Target for Vaccine Development. Journal of Virology 94, (2020).
  5. Dai, L. & Gao, G. F. Viral targets for vaccines against COVID-19. Nature Reviews Immunology 21, 73–82 (2021).
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